An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover relative bioavailability study of Glimepiride Oral Disintegration Strip 1 mg manufactured by: ZIM Laboratories, Nagpur, India, manufactured for: Sanofi Healthcare India Private Limited and Amaryl (Glimepiride) Tablet 1 mg Manufactured by Sanofi-Aventis Deutschland GmbH, Germany in healthy adult human subjects under fasting conditions. (Project Number: AZBE022406, Sponsor Study Code: BDR16756, Version: 1.0, Date: 09-APR-2024).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To assess the relative bioavailability of Glimepiride Oral
研究概览
简要总结
This study is an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover relative bioavailability study of Glimepiride Oral Disintegration Strip 1 mg manufactured by: ZIM Laboratories, Nagpur, India, manufactured for: Sanofi Healthcare India Private Limited and Amaryl® (Glimepiride) Tablet 1 mg Manufactured by Sanofi-Aventis Deutschland GmbH, Germany in healthy adult human subjects under fasting conditions that will be conducted at single center in India. The primary outcome is to assess the relative bioavailability between Glimepiride Orally Disintegrating Strip 1 mg (Test) versus Amaryl Tablet 1 mg (Reference). The secondary outcomes will be to monitor the safety and tolerability after single oral administration under fasting and fed condition of Glimepiride Orally Disintegrating Strip 1 mg (Test) versus Amaryl Tablet 1 mg (Reference).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy male literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.
- •24.9 Kg/m2 and with weight minimum of 45 kg.
- •Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- •Non-smokers as evident from the history obtained will be included.
- •Normal or clinically insignificant ECG.
- •Negative urine test for drugs of abuse, alcohol breath analysis.
- •Subjects having calculated eGFR value at the time of screening ≥ 60 ml/min – period.
- •Volunteers who are willing to use acceptable methods of contraception.
- •Volunteers who can give written informed consent and communicate effectively.
排除标准
- •History of any major surgical procedure in the past 03 months.
- •Subjects with intolerance to lactose, fructose or galactose.
- •History or presence of asthma, urticaria or other significant allergic reactions.
- •History or presence of significant recent trauma.
- •History or presence of cancer or basal or squamous cell carcinoma.
- •Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/ immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant disease as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the medication.
- •History of chronic alcoholism/ chronic smoking/ drug of abuse.
- •Volunteers with known hypersensitivity to Glimepiride or any of the excipients.
- •History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing.
- •Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV1&2) antibodies.
- •Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Glimepiride or any other medication judged to be clinically significant by the investigator.
- •History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
- •Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
- •History of consumption of one or more of the below, 48 hours prior to dosing:.
- •Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator.
- •Volunteers who are dysphagic.
结局指标
主要结局
To assess the relative bioavailability of Glimepiride Oral
时间窗: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose
Disintegration Strip 1 mg (Test) versus Amaryl Tablet 1 mg
时间窗: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose
(Comparator) after single oral administration under fasting
时间窗: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose
conditions.
时间窗: 00.00 (Pre-dose), 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 05.00, 06.00, 08.00, 10.00, 12.00, 24.00, and 36.00 hours post dose
次要结局
- Secondary objective:(- Additional PK parameters for Glimepiride)
研究者
Dr S Sathish Kumar
Azidus Laboratories Ltd.